Data presented today at the EULAR 2011 Annual Congress demonstrated that initial treatment with adalimumab (Humira, ADA) plus methotrexate in early RA patients can provide high levels of disease control in many patients, and may also offer the opportunity to change future treatment options for some.
Results of a study of 1032 patients with early (less than one year), active RA initially assessed response to treatment after 26 weeks with ADA 40mg every other week + MTX versus MTX alone. Results show that 44% of patients treated with the combination therapy achieved the target of sustained low disease activity at week 26, versus 24% of those treated with MTX alone. Patients reaching the target on ADA+MTX were considered responders and then further randomised to continue or withdraw from treatment with ADA 40mg every other week.
Patients who continued treatment maintained good clinical, radiographic and functional responses through to week 78, including a high proportion achieving higher measures of disease control. 77% achieved ACR70*, 86% reached DAS remission (DAS28≤2.6**) and 89% had no radiographic progression***. Interestingly, the majority of patients who had treatment withdrawn also showed good outcomes: 65% and 66% achieved ACR70 response and DAS28≤2.6**, respectively, and 81% showed no radiographic progression. The results in those patients discontinuing ADA indicate that it may be possible to withdraw ADA treatment in specific patients, without impacting long term patient outcomes.
"Data from the OPTIMA study has confirmed previous studies in showing that initial and continued adalimumab treatment in early RA can ensure that higher levels of disease control can be achieved and maintained," said Professor Paul Emery, Leeds Teaching Hospital, Leeds, England, and EULAR President. "Importantly, results of this first global study assessing biologic free disease control demonstrate that it may be possible to successfully withdraw anti-TNF therapy in certain patients and maintain long term positive outcomes although further studies in this area are needed."
Safety findings over the whole study period were generally similar to the profile seen with anti-TNF treatments in the treatment of active RA. Adverse events were evaluated for 850 patients who received ADA: serious adverse events included 9 deaths (1.0 per 100 patient years (/100PY)), 39 serious infections (4.4/100PY); 11 malignancies (1.2/100PY) including 5 non-melanoma skin cancers (0.6/100PY); 8 opportunistic infections (excluding tuberculosis) (0.9/100PY); with 4 confirmed as tuberculosis (0.5/100PY).